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Sandoz launches high-concentration biosimilar of AbbVie’s Humira in the US

Sandoz, a Novartis division, has announced the US launch of its citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz) – a biosimilar version of AbbVie’s Humira (adalimumab). Hyrimoz HCF (100mg/mL) is approved to treat all indications that are no longer covered by the reference medicine regulatory exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Biosimilars, according to the US Food and Drug Administration (FDA), are biological products that are highly similar to an existing FDA-approved reference product. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower healthcare costs. Hyrimoz was approved by the FDA in 2018 at a concentration of 50mg/mL. The HCF offers a 50% reduction compared to the original concentration and can decrease the number of injections required for people who need at least 80mg ...
- Source: drugdu
- 155
- July 7, 2023
3D frame helps the mask fit

If the face mask fits, it’s much safer—say Flinders University medical experts after developing a low-cost way to customize N95 filtering facepiece respirators (FFRs) for health workers on the front line of the pandemic and respiratory viruses such as influenza. Researchers say the decrease in “leakage” and greater comfort for the wearer whose face has been personally fitted could also have applications to improving respirator and mask safety in a wide range of industrial settings in health care and beyond. The article, “Personalized 3D-printed frames to reduce leak from N95 filtering facepiece respirators: a prospective crossover trial in health care workers” has been published in the Journal of Occupational and Environmental Hygiene. “Individually and anatomically personalized 3D-printed face frames represent a rapidly scalable technology to significantly improve health care worker protection and comfort, and fit-testing pass rates,” says Flinders University cardiology research fellow Darius Chapman. Working with public hospital workers ...
- Source: drugdu
- 156
- July 6, 2023
Researcher reach milestone in the treatment of anemia in chronic lymphocytic leukemia

In people with myelodysplastic neoplasms (MDS), a usually benign form of chronic lymphocytic leukemia, the body produces too few functional blood cells. Affected individuals suffer from anemia—a lack of red blood cells or hemoglobin—which can be a precursor to acute leukemia. Compared to the standard treatment, luspatercept can increase hemoglobin levels in MDS patients and help them to avoid blood transfusions. These are the findings of an international clinical trial led by Professor Uwe Platzbecker from Leipzig University and the University of Leipzig Medical Center in collaboration with a large international research team. Every year, around 4,000 people in Germany alone are diagnosed with myelodysplastic neoplasms (MDS). In these patients, the healthy maturation of blood cells is disrupted, which can lead to anemia, infections and an increased risk of bleeding. High-risk MDS is characterized by rapid progression, severe symptoms and often a transition to acute leukemia that results in a ...
- Source: drugdu
- 143
- July 6, 2023
FDA says Ipca Labs failed to address quality issues with bad API batches

Tyler Patchen News Reporter Ipca Laboratories, an India-based maker of active pharmaceutical ingredients, was cited for several quality and testing issues during a recent FDA inspection. The FDA inspected an Ipca manufacturing facility in Ratlam, India, between June 5 and June 13, and investigators made a total of 11 observations. The FDA said the company failed to properly investigate root causes for deficient API batches. In April, Ipca had received a complaint saying there were “metal-like particles and magnet particles” in some products. The regulator also said the facility’s quality unit did not issue a recall of an unnamed product that did not meet specific impurity standards. Inspectors found that Ipca did not conduct the correct contamination testing of a drug substance that was redacted from the report and therefore was not aware of potential hazards. Laboratory tests on manufactured APIs were found to be deficient by inspectors, as were ...
- Source: drugdu
- 172
- July 6, 2023
Amgen and Horizon call FTC’s attempt to block $28B merger unconstitutional in counterclaims

Nicole DeFeudis Editor Amgen and Horizon filed counterclaims against the FTC, alleging the agency’s attempt to block their nearly $28 billion merger “runs roughshod” over provisions of the Constitution. The FTC in May filed a lawsuit in federal court trying to scuttle Amgen’s proposed buyout of Horizon. The agency’s claims center around bundling, a scrutinized industry practice that involves offering multi-product discounts that make it difficult for rivals to compete. Amgen and Horizon previously called the case “as misguided as it is unprecedented,” and they argued the proceeding is unconstitutional on Thursday. Amgen and Horizon argue FTC’s suit to block $28B merger is ‘as misguided as it is unprecedented’ Defendants alleged in new counterclaims that the FTC’s effort violates multiple provisions of the Constitution, including the due process clause of the Fifth Amendment “because the FTC will play the role of investigator, prosecutor and judge.” “The FTC’s case is wholly novel ...
- Source: drugdu
- 177
- July 6, 2023
Global efforts to reduce infectious diseases must include older children and adolescents

Global efforts to reduce infectious disease rates must have a greater focus on older children and adolescents after a shift in disease burden onto this demographic, according to a new study. The research, led by Murdoch Children’s Research Institute and the Institute for Health Metrics and Evaluation, has found that infectious disease control has largely focused on children aged under five, with scarce attention on young people between five and 24 years old. Published in The Lancet, the study found three million children and adolescents die from infectious diseases every year, equivalent to one death every 10 seconds. It looked at data across 204 countries between 1990 and 2019 from birth to 24 years of age. Diarrhea, pneumonia and malaria account for two-thirds of infectious diseases and death among children and adolescents. HIV and tuberculosis were the leading causes among older adolescents. The shift in infectious disease burden from young ...
- Source: drugdu
- 163
- July 6, 2023
Omega-3 rich oil can prevent damage to honey bee mitochondria caused by pesticides

New research suggests that the use of an omega-3 rich oil called “ahiflower oil” can prevent damage to honey bee mitochondria caused by neonicotinoid pesticides. This research is part of an ongoing project by PhD student Hichem Menail of the Université de Moncton in New Brunswick, Canada. “Pesticides are a major threat to insect populations and as insects are at the core of ecosystem richness and balance, any loss in insect biodiversity can lead to catastrophic outcome,” says Mr Menail, adding that pesticide-related pollinator declines are also a huge concern for food crops globally. Imidacloprid, a neonicotinoid pesticide, is one of the world’s most commonly used insecticides. Imidacloprid was banned for outdoor use by the EU in 2018, along with two other major neonicotinoids, but their use continues around the world, including the United States of America. Mr. Hichem Menail (PhD student, Université de Moncton in New Brunswick, Canada) said, ...
- Source: drugdu
- 137
- July 6, 2023
FDA approves Skyline Therapeutics’ IND for macular degeneration trial

Chinese gene therapy company Skyline will initiate a global trial investigating a gene therapy to treat neovascular age-related macular degeneration (nAMD), after receiving clearance from the US Food and Drug Administration (FDA). The FDA granted the company’s investigational new drug (IND) application for a Phase I/IIa trial of SKG0106 – a one-time intravitreally delivered adeno-associated virus (AAV) gene therapy. Skyline has not disclosed when it expects to initiate the trial. Skyline Therapeutics’ candidate encompasses a new AAV capsid and unique transgene genome encoding an anti-VEGF protein. Vascular endothelial growth factor (VEGF) is a protein that promotes the growth of new blood vessels and also makes vessels more permeable or leaky. Patients with macular degeneration secrete too much of this protein. The company’s anti-angiogenic treatment is able to suppress neovascular lesions at a low dose with durable effects from a single injection. The prevention of neovascularisation provides relief of vascular leakage ...
- Source: drugdu
- 150
- July 6, 2023
Labcorp forms spin-off of Fortrea

Labcorp, the laboratory service supplier based in the US, has completed the spin-off of Fortrea, to create the newly formed contract research organisation that will give pharmaceutical and biotechnology organisations access to global Phase I-IV clinical trial management, patient access and technology solutions. Fortrea made a cash distribution of around $1.6bn as partial consideration for the assets that Labcorp contributed to Fortrea in connection with the spin-off. Labcorp will use the distribution toward a $1bn accelerated share repurchase program and pay down $300m of debt maturing this year. Whatever is left of the funds will be distributed among shareholders. The spin-off distribution was completed on 30 June 2023 to stockholders of record as of the close of business on 20 June 2023. Labcorp’s stockholders each received one share of Fortrea common stock for every share of Labcorp common stock they held as of the record date. The spin-off will pass ...
- Source: drugdu
- 162
- July 6, 2023
Regeneron’s high-dose Eylea hit with surprise FDA rejection over manufacturing hiccups

The FDA turned down the closely watched eye med because of manufacturing problems the agency spotted at a third-party drug filler, Regeneron said in a release. The FDA didn’t flag any issues with the med’s efficacy and safety or its labeling and drug substance manufacturing and didn’t request additional clinical data, the company said. In a race against Roche’s Vabysmo, Regeneron and its partner Bayer’s application for the 8 mg Eylea (aflibercept) version was accepted in February, hoping for approval in wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. Despite the hurdle, Regeneron remains “committed to working closely with the FDA and the third-party filler” to introduce the high-dose drug, the company said. A Regeneron spokesperson declined to comment on the identity of the filler or where it’s located. Elsewhere, the FDA recently published a Form 483 against an Eli Lilly plant in Indianapolis after an inspection in ...
- Source: drugdu
- 132
- July 6, 2023

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